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This document describes how the review of the quality management system shall be conducted to ensure ongoing adequacy, suitability and effectiveness. The Management Review will be conducted at planed intervals to assess opportunities for improvement and the need for changes to the QMS, including the quality policy and quality objectives.
The Management team includes C-level executives and other key personnel. The Management team is responsible for ensuring that the QMS is established, implemented and maintained in accordance with the requirements of ISO 13485:2016 and other applicable regulatory requirements alongside the Quality Team. The Management review process is led by the quality team and is conducted at least once per year.
The management team includes the following individuals:
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The following data shall be provided to the Management Review as input. It can include but is not limited to:
Output from the Management Review Report shall be recorded according to SOP Document and Record Control and should at a minimum provide information related to decisions and actions made concerning:
As part of this process, the Management also reviews the organization's quality policy, quality objectives and
the status of previous strategic goals. It defines new strategic goals for the next review period.
Based on findings during the Management Review, the Management may define further measures such as the
revision of single processes, product changes or the (re-)allocation of resources.
The organization shall conduct a Management Review (at least) once per year. Ideally, the review is conducted before an external audit (e.g. by a Notified Body) and following when audit reports from internal auditing are available.
At the beginning of every review period, Management together with the quality team defines key performance indicators (KPIs) for the QMS processes of the company. The quality objectives are reviewed for continued adequacy. The list of KPIs is maintained in the Annex of this SOP. KPIs can be reviewed or changed at any time during the review period if necessary.
The results of this process step are communicated to functional groups within the organization, most often through process or organizational leaders.
At the end of a review period, the quality team works with the responsible parties to collect data input related to each KPI and analyze it against the pre-defined KPI criteria in preparation for the Management Review. Additional information outside of the pre-defined KPIs can be investigated to identify non-conformities and to provide a additional assessment of the adequacy, suitability and efficacy of the QMS.
Management Review is performed by completing the Management Review Report. The Management Team and quality team are responsible to evaluate the results against the pre-defined criteria and formulate an assessment of the adequacy, suitability and efficacy of the QMS. If KPIs are not met, the Management team defines measures for improvement if needed. Just because a KPI is not met does not mean that improvement or changes are required. The results of the Management Review are documented in the Management Review Report.
Where necessary, the Management team can establish new or revised process KPIs as well as quality objectives for the next review period.
